Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

57768421.0.0000.5558

Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

2022-06-22

2024-06-01

2026-06-01

Recruiting

Early phase I

100

Inclusion Criteria: * Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis * Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase * Agree and sing informed consent form Exclusion Criteria: * Previous treatment with leishmanicidal drugs in the last 6 months * Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms) * Serum creatinine or urea 1.5 times the upper limit of normal * Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus * history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline * Pregnant and breastfeeding women * Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-09-15